Heat-sealing device.

(a) Identification. A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9. [45 FR 60650, Sept. 12, 1980, as amended at 65 FR 2311, Jan. 14, 2000]